The Centers for Medicare and Medicaid Services (CME) decided to review their policies pertaining to paying for Provenge, which costs $93,000 per man. Since the hearings which were held a number of months ago, we have not heard any feedback. Despite this, most of the regions have been paying for the treatment, however there have been a few hold outs.
Finally we have heard, the advisory committee has recommended paying for the vaccine. Their proposal will be subject to public comment for 30 days, and a final decision will be issued 60 days after that.
“The evidence is adequate to conclude that” Provenge improves health outcomes for Medicare beneficiaries” with metastatic prostate cancer, “and thus is reasonable and necessary for that indication,” the advisory committee said in announcing its decision.
Despite that Medicare is not supposed to take cost into consideration when making such rulings, the decision by CMS to launch a formal examination raised concerns among cancer experts, drug companies, lawmakers, prostate cancer patients and advocacy groups, including Malecare.
Provenge, which received Food and Drug Administration approval in April, is the latest in a series of new, high-priced cancer treatments that will also probably be reviewed by CME.
Medicare’s decision will have a major effect on Provenge’s accessibility as private insurers tend to follow Medicare’s lead.
Medicare officials have said Provenge’s price tag was not an issue, and some outside experts said the agency was motivated more by questions about the vaccine’s effectiveness and concerns that it might be used “off-label” for purposes not specifically approved by the Food and Drug Administration.
In November, the Medicare Evidence Development and Coverage Advisory Committee endorsed the vaccine, saying there was sufficient evidence that Provenge could help extend patients’ lives. The committee, however, also voted that there was inadequate evidence that Provenge would help other kinds of patients, such as those who were either sicker than those studied to get Provenge approved or not as sick. This confirms our belief that Medicare will read the FDA approval to the very period.
Medicare usually covers new cancer drugs once they have been approved by the FDA. The decision in June to scrutinize Provenge prompted several members of Congress to question the action. Supporters of the drug’s approval inundated the agency with hundreds of thousands of comments, including many from supporters of Malecare.
Joel T. Nowak, M.A, M.S.W.